Kaohsiung Armed Forces General Hospital
Kaohsiung City, 80284, Taiwan
Location contact
Chih-Hsuan Chang, MS
CONTACT
Hui-Ru Lin, MS
PRINCIPAL_INVESTIGATOR
Yung-Kuo Lee, PhD
CONTACT
NCT Number: NCT07666633
Newly graduated nurses often experience high levels of psychological stress, sleep disturbance, fatigue, and burnout during the early transition into clinical practice. Early identification of burnout and retention risk may help improve mental well-being, workforce stability, and quality of patient care.
This longitudinal observational study aims to develop a non-invasive sleep-based prediction platform for assessing burnout and retention risk among postgraduate nurses. Participants will undergo repeated psychological assessments and non-contact sleep monitoring during the study period. Sleep-related physiological parameters, including sleep efficiency, sleep structure, heart rate variability, and respiratory variability, will be collected together with validated psychological questionnaires.
The study will further apply machine learning and artificial intelligence approaches to integrate longitudinal physiological and psychological data for risk prediction and early identification of burnout-related conditions. The findings may support future development of precision mental health monitoring and supportive management strategies for high-stress healthcare workers.
Trial opening soon.
Get Notified20 year–65 year
All sexes
Observational
Kaohsiung City, 80284, Taiwan
Chih-Hsuan Chang, MS
CONTACT
Hui-Ru Lin, MS
PRINCIPAL_INVESTIGATOR
Yung-Kuo Lee, PhD
CONTACT
Postgraduate nurses frequently experience substantial psychological and physiological stress during the transition from academic training to clinical practice. Heavy workloads, rotating shifts, emotional demands, and adaptation to clinical environments may contribute to sleep disturbance, fatigue, burnout, and increased turnover intention. Previous studies have demonstrated significant associations between sleep quality, autonomic nervous system regulation, emotional distress, and occupational burnout among healthcare workers, particularly in shift-working nurses.
Current psychological assessments mainly rely on self-reported questionnaires and short-term evaluations, which may not adequately capture dynamic physiological changes over time. Recent advances in non-contact sleep monitoring technologies provide opportunities for continuous and low-burden collection of sleep-related physiological data in natural sleep environments. In addition, artificial intelligence and machine learning approaches may improve early identification of individuals at higher risk of burnout and retention problems.
This study is a prospective longitudinal observational study designed to investigate the relationship between sleep-related physiological characteristics, psychological status, burnout risk, and retention risk among postgraduate nurses during the early clinical transition period.
Eligible participants will include newly employed postgraduate nurses within three months of clinical employment. Participants will complete validated psychological questionnaires, including the Brief Symptom Rating Scale-5 (BSRS-5), Chinese Health Questionnaire-12 (CHQ-12), Pittsburgh Sleep Quality Index (PSQI), Karolinska Sleepiness Scale (KSS), and Copenhagen Burnout Inventory (CBI). In parallel, participants will undergo non-invasive and non-contact sleep monitoring under natural sleep conditions. Sleep-related physiological parameters including sleep efficiency, sleep stage distribution, deep sleep proportion, REM sleep stability, heart rate variability, and respiratory variability will be analyzed.
Repeated assessments will be conducted longitudinally at baseline, 3 months, and 6 months. Statistical analyses will include descriptive statistics, longitudinal analyses, generalized estimating equations, mixed-effects models, and survival-related analyses when applicable. Machine learning and deep learning approaches, including Random Forest, XGBoost, and longitudinal prediction models, will be applied to develop predictive models for burnout and retention risk.
The study does not involve therapeutic intervention, medication administration, or changes to work schedules. All collected data will be de-identified and managed according to institutional research ethics and privacy protection regulations. The results of this study may contribute to the future development of precision mental health monitoring systems and supportive management strategies for high-stress healthcare professionals.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will undergo non-invasive and non-contact sleep monitoring under natural sleep conditions. The monitoring system will collect sleep-related physiological signals and estimate sleep parameters, including sleep efficiency, sleep stage distribution, deep sleep proportion, REM sleep stability, heart rate variability, and respiratory variability. This procedure is used for observational data collection only and does not involve treatment or changes to clinical work schedules.
Time frame: Baseline, 3 months, and 6 months
Assessment of burnout severity using the Copenhagen Burnout Inventory (CBI), a validated questionnaire for evaluating personal and work-related burnout symptoms. The CBI score ranges from 0 to 100, with higher scores indicating greater burnout severity.
Time frame: Baseline, 3 months, and 6 months
Assessment of sleep quality using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire for evaluating subjective sleep quality and sleep disturbance. The PSQI global score ranges from 0 to 21, with higher scores indicating poorer sleep quality.
Time frame: Baseline, 3 months, and 6 months
Assessment of psychological distress using the Brief Symptom Rating Scale-5 (BSRS-5), a validated questionnaire for evaluating anxiety, depression, hostility, interpersonal sensitivity, and insomnia symptoms. The BSRS-5 total score ranges from 0 to 20, with higher scores indicating greater psychological distress.
Time frame: Baseline, 3 months, and 6 months
Assessment of mental health status using the Chinese Health Questionnaire-12 (CHQ-12), a validated questionnaire for evaluating psychological well-being and minor psychiatric morbidity. Higher scores indicate poorer mental health status.
Time frame: Baseline, 3 months, and 6 months
Assessment of subjective sleepiness using the Karolinska Sleepiness Scale (KSS). The KSS score ranges from 1 to 9, with higher scores indicating greater subjective sleepiness.
Time frame: Baseline, 3 months, and 6 months
Assessment of sleep efficiency derived from non-invasive sleep monitoring. Higher values indicate better sleep efficiency.
Time frame: Baseline, 3 months, and 6 months
Assessment of deep sleep proportion derived from non-invasive sleep monitoring. Higher values indicate a greater proportion of deep sleep during total sleep time.
Time frame: Baseline, 3 months, and 6 months
Assessment of REM sleep stability derived from non-invasive sleep monitoring.
Time frame: Baseline, 3 months, and 6 months
Assessment of autonomic nervous system regulation using heart rate variability derived from non-invasive sleep monitoring.
Contact information is provided by the study sponsor or research team.
Chih-Hsuan Chang, MS
CONTACT
Yung-Kuo Lee, PhD
CONTACT
Kaohsiung Armed Forces General Hospital
Other
Development of a Non-Invasive Sleep-Based Prediction Platform for Burnout and Retention Risk Among Postgraduate Nurses: A Psychophysiological and AI-Driven Approach for High-Stress Clinical Populations
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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